Comparison of the Tolerability of Two Formulations of Hypertonic Saline in Cystic Fibrosis Patients
NCT ID: NCT01658449
Last Updated: 2012-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2009-12-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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group A
Inhalable Hypertonic saline 7% + Hyaluronan 0.1%
Administration of Inhalable Hypertonic saline 7% + Hyaluronan 0.1% 5 ml twice a day, after bronchodilator for one month.
group B
Inhalable Hypertonic saline 7%
Administration of Inhalable Hypertonic saline 7% 5 ml twice a day, after bronchodilator for one month.
Interventions
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Inhalable Hypertonic saline 7% + Hyaluronan 0.1%
Administration of Inhalable Hypertonic saline 7% + Hyaluronan 0.1% 5 ml twice a day, after bronchodilator for one month.
Inhalable Hypertonic saline 7%
Administration of Inhalable Hypertonic saline 7% 5 ml twice a day, after bronchodilator for one month.
Eligibility Criteria
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Inclusion Criteria
* \> 8 year-old
* clinically and therapeutically stable disease in the last 30 days;
* Forced Expiratory Volume in one second (FEV1) ≥ 50% of predicted value;
* intolerance (cough, throat irritation, saltiness) to previous administration of 5.8% hypertonic saline solution.
Exclusion Criteria
* Burkholderia cepacia infection;
* infective exacerbation requiring antibiotic treatment in the 15 days preceding enrolment;
* patient non compliant to standard therapy;
* Lung transplant;
* Patient unable to perform reproducible spirometry;
* Intolerance to β2 bronchodilators;
* Concurrent enrolment in other clinical trials;
* Plasmatic creatinine and transaminases more than twice the normal values.
8 Years
ALL
No
Sponsors
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Ospedale Civile Ca' Foncello
OTHER
Responsible Party
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Locations
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centro Fibrosi Cistica
Treviso, Italy, Italy
Countries
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References
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Ros M, Casciaro R, Lucca F, Troiani P, Salonini E, Favilli F, Quattrucci S, Sher D, Assael BM. Hyaluronic acid improves the tolerability of hypertonic saline in the chronic treatment of cystic fibrosis patients: a multicenter, randomized, controlled clinical trial. J Aerosol Med Pulm Drug Deliv. 2014 Apr;27(2):133-7. doi: 10.1089/jamp.2012.1034. Epub 2013 Jun 8.
Other Identifiers
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HS/2009 HYANEB
Identifier Type: -
Identifier Source: org_study_id